drugset / Press release

Immedica's partner Actinium announces oral presentation at ASH annual meeting on Iomab-B outcomes data for TP53 gene mutation from the SIERRA trial

2023-11-14 · Immedica Pharma AB · original immedica.com ↗

Stockholm, November 14 , 2023 – Immedica’s partner Actinium Pharmaceuticals, Inc. has announced that three abstracts detailing results from the completed Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) have been accepted for presentation at the 65th Annual American Society of Hematology Annual Meeting & Exposition (ASH) being held in San Diego on December 9-12, 2023. Outcomes of patients with a TP53 gene mutation enrolled in the SIERRA trial have been accepted for an oral presentation and results detailed in the abstract include the following: Median Overall Survival (OS) of patients with TP53 mutation receiving Iomab-B and a hematopoietic stem cell transplantation (HSCT) was 5.49 months compared to 1.66 months in patients who did not receive Iomab-B (hazard ratio=0.23, p=0.0002) Median OS of patients without TP53 mutation receiving Iomab-B was 6.37 months and for patients with TP53 mutation it was 5.72 months, demonstrating Iomab-B's mutation agnostic mechanism and ability to overcome TP53 gene mutations 24% of patients (37/153) enrolled on the SIERRA trial had a TP53 mutation, with 17 being randomized to the Iomab-B arm and 20 randomized to the control arm Detailed results will be presented in an oral presentation on December 10, 2023, as follows: Publication Number: 469 Title: 131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML Submission ID: 182177 Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Novel Conditioning Regimens for Myeloid Malignancies Session Date: Sunday, December 10, 2023 Session Time: 9:30 – 11:00 AM Pacific Time Presentation Time: 9:30 AM Room: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 18-19 Additional SIERRA data will be presented in two poster presentations as follows: Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster I Session Date: Saturday, December 9, 2023 Presentation Time: 5:30 – 7:30 PM Pacific Time Location: San Diego Convention Center, Halls G-H Publication Number: 2159 Title: 131I-Apamistamab Effectively Achieved Durable Responses in Patients with R/R AML Irrespective of the Presence of Multiple High-Risk Factors Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster II Session Date: Sunday, December 10, 2023 Presentation Time: 6:00 – 8:00 PM Pacific Time Location: San Diego Convention Center, Halls G-H Publication Number: 3529 Title: High-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT Demonstrated a Dose-Response for Durable Complete Remission in Patients with R/R AML About Actinium Pharmaceuticals, Inc. Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium's technology platform is the basis for collaborations with Astellas Pharma and AVEO Oncology/LG Chem Life Sciences for solid tumors. Actinium holds more than 220 patents and patent applications. For more information, please visit: https://www.actiniumpharma.com About Immedica Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within genetic & metabolic diseases, hematology & oncology and specialty care. Immedica was founded in 2018 by the investment company Impilo and Buy-in-Management. Today Immedica employs more than 100 people across Europe and the Middle East. For more information visit www.immedica.com Immedica contact: Linda Holmström Head of Communication [email protected] + 46 708 73 40 95 We believe we have an important role to fill in society – bringing new, innovative treatments to patients with rare diseases. Focus areas are within RARE metabolic, RARE neurology, RARE hematology & oncology and specialty care. We operate products from phase 2 and all the way to mature products. ESG is an integrated part of our business model. Stay up to date with our latest news. Telephone: +46 (0) 8 533 39 500 E-mail: [email protected]

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